The Assertive Cancer Patient

More on T-DM1

Well, as a woman with advanced breast cancer who HAS RUN OUT OF TREATMENT OPTIONS, I have to disagree with Breast Cancer Action on this one. 

See the letter re: T-DM1: T-DM1 Breast Cancer Action Letter

I understand the arguments the group advances, I even agree with them up to a point. But the whole approval process is incredibly long and cumbersome, and getting drugs outside that process--despite what you might think when you hear the term "compassionate use"--is almost impossible, in my experience. 

As I said in an earlier post, I don't think this will hurt my ability to get the drug in a Phase II trial. There is a trial opening here in Seattle soon, unless this news somehow makes the folks at the UW less enthusiastic about getting the trial through their own approval process. But I don't see why that should be. 

I know the risks associated with this drug. (I haven't posted them yet, but I will.) There is a very long list of quite nasty potential side effects. I also know that some women have lived for a year or more on this drug and others have seen their cancer go into clinical remission. I'll take my chances.

See also: T-DM1

@ Jeanne Sather 2010. 

T-DM1 News (???)

I'm not sure what this news item about T-DM1 means for me, if anything. T-DM1 is the new drug that I plan to get in a clinical trial once I've finished my current cyberknife treatments. 

I think it's the right drug for me--pretty much the only drug, really--and there is a trial opening at the UW/SCCA soon (although THAT is held up in a committee, I'm told). 

In any case, the drug maker failed to win "accelerated approval" for T-DM1, "because all available treatment choices for metastatic breast cancer ... had not been exhausted."

Well, here is one woman for whom all options HAVE been exhausted. But I'm not going to panic, because I don't think this news affects the clinical trial, but it might affect how soon the drug is available outside of a trial. And of course if it works for me, I'm going to want to be able to get it. 

I have an appointment with my medical oncologist, Dr. Lee the First, in a week or so, and I'll dump this one on him. 

Read: No FDA Fast Track for T-DM1

Read more: T-DM1

Feeling cynical about drug companies? You're not alone. Genentech will lose an estimated $1 billion a year in sales of Avastin, now that its effectiveness in treating breast cancer is in doubt. Gotta make that income up somewhere. 

@ Jeanne Sather 2010. 

Cancer? Expensive? They're Kidding, Right?

Here's another one of those "duh" headlines. Or at least it's a big duh to those of us living with the disease of the crab. 

Or should we call it "the crabby disease"? The "deadly crabby disease"?

See: Cancer Is the World's Costliest Disease

Doesn't that make me feel special?

If I had a little more time this morning, I'd slide into a rant on The Cancer Industry and where the money really goes. I don't have all the hard numbers that I'd like to have, like how much money goes directly to cancer patients to help them deal with their illness, and how much goes to marketing the various competing cancer centers, and how much it costs to put on one teeny tiny clinical trial ... 

Consider it ranted and carry on. 

Support this cancer patient:

@ Jeanne Sather 2010. 

The Best Cure ...

No, I haven't discovered a cure for cancer, sorry. 

But I do know the best cure for the state I've been in for the past few days, ever since Dr. Lee told me in a phone call on Tuesday that my cancer is progressing pretty much everywhere. At least, this is the best cure for me: And it is to TAKE ACTION.

As I wrote yesterday, Dr. Lee's staff refused to get me in to see him so that I could get answers to my questions about the four tumors in my spine that are moving toward (or possibly pressing on) my spinal cord (you know, where all the nerves are). I also needed more info about the tumor in my sacrum that is causing the numbness and tingling down my left leg, and I wanted to tell him that I wanted to move ahead with all possible speed on getting into the T-DM1 trial in Highland, California. 

Does anyone seriously think I could wait A WEEK to get answers to these questions? 

I was lying in bed wondering if I was going to wake up and find myself paralyzed from one of the mets in my spine ... not a prescription for a good night's rest. 

So, this is what I've done so far:

Yesterday, my friend Laurie drove me up to Via Radiology to pick up the copies of my scans on disc to take to Dr. Eulau, my radiation oncologist. I had talked to Dr. E on the phone this week and we had also e-mailed a couple of times, and he said he needed the actual scans before he made any recommendations (of course). He said I should bring them to his office and they would work me in to talk to him. 

So we showed up at Dr. E's office at 2, an hour before I was due for my radiation therapy appt. (which is under Dr. E's care) across the street. 

Fortunately for me, his 2 o'clock patient had canceled, so he had plenty of time to talk. First, he took some time to study the scans, and then he called me in. 

The bad news: Of all the tumors that are larger (lungs, lymph nodes, spine, sacrum, and various other spots in the bone), he was most concerned about the one in my sacrum, which is 7 cm long. That is the largest tumor I have ever had. The one that broke my upper right arm way back when my cancer first metastasized was "only" 5 cm, and I thought that was huge at the time. 

We discussed, but did not make a final decision, about the best way to treat this one: conventional radiation, cyberknife, or with systemic treatment in the clinical trial (T-DM1). 

The other spot he was most concerned about is one of the tumors in my spine, at T-9, I believe. On the MRI I could see that the tumor is bulging out of the bone and appears to be touching the spinal cord. Dr. E says it isn't putting pressure on the spinal cord yet, or I would know it, but it is very very close. 

That one we can't radiate, because the area has already been treated with conventional radiation. So the options are cyberknife or the systemic treatment (or both, actually, cyberknife first, then the trial). Dr. Eulau is going to discuss the options for both of these trouble spots with my other two doctors, Dr. Doug Lee (Dr. Lee the First) and Dr. Brian Lee (Dr. Lee the Second, or Cyberknife Guy). 

Dr. Eulau agrees on my choice of T-DM1 as my next treatment, and he made a call to Tricia, the point person on the trial in Highland, because I couldn't move ahead on making plans to go there until one of my doctors had confirmed to them that my cancer has indeed progressed on my most recent treatment regimen (THAT's one of the things I wanted Dr. Lee to do for me on Wednesday ...)

I also asked him if Dr. Eulau's office could request all my treatment records for me, because I am going to need to take those to California with me, and he said they could do that. 

Then we went across the street to the Gowned Waiting Room, and I got my zap. 

On the way home, Laurie suggested a milkshake, and we picked up shakes at Kidd Valley (they have the best--McDonald's shakes don't begin to compare--not that I ever eat at McD's) and then I came home and collapsed on the couch. But my day wasn't done--I also had a long e-mail from Tricia, answering some questions I had e-mailed to her the day before, and then I called her and we talked for a while. 

By the end of the phone call, I had a tentative appt. to be seen by one of the study doctors in Highland on July 29. 

Then I had to check with Monica, who has agreed to fly with me, and Megan, a friend in the L.A. area who had already offered me a place to stay, to see if those dates would work. 

They do, and I now have a firm appt. with Dr. Ibrahim on July 29. 

Next task: To find free airline flights. I have been told that the American Cancer Society will pay for one free flight for a cancer patient and companion to travel for medical treatment, but I sure can't find that info online. If anyone has the contact info for this program, please e-mail it to me ASAP. 

Second task: To gather up ALL of my medical records for the past 12 years, which are at three different cancer centers. This is going to be fun!

But I've already asked for my records from Swedish, I'm going to go in and get the records from Dr. Lee's clinic on Tuesday, and then I will tackle the U of Washington/SCCA--these are the folks who, last time I requested a complete copy of my medical records, which were three binders thick, gave me only about one sixth of the total pages and they were out of order and pages were missing. They also didn't contain the info I needed. 

That will not happen this time, if I have to stand over them and mark every page. 

Friday

Plans for today? To take it easy. I have a necklace to mail and a couple of things to pick up at the grocery store. I'll do these errands on my way to treatment, and yes, I have a ride. My friend Linda, mother of Megan (the college student), is driving me. 

@ Jeanne Sather 2010. 

The T-DM1 Road Trip Comes to Seattle

So, I've been on the phone with folks at Genentech the past couple of days. First with their clinical trials hotline, and then with a study coordinator in Highland, California, which is supposed to be the second site opening to give T-DM1 on expanded access. 

Now, Southern California is not as difficult a place for me to travel back and forth to as Florida, but I still had some reservations that I would be able to fly down there every three weeks for treatment and so on. I was pursuing it, however, and it looks like I made it through all the hoops (and there are a LOT of hoops), with the possible exception of my cancer progressing on my present regimen. 

I certainly thought it was progressing, but Dr. Lee apparently told the study coordinator, Tricia is her  name, that I was doing well on my present regimen. Oops. 

Be that as it may, Tricia and I worked our way through all the questions--reasons to include me in the study and reasons to exclude me from the study, and she thinks I qualify, so the nest steps are signing consent forms, and forms that allow them to get all my medical records, and then scheduling an appt. to fly down there for the first appointment, which would include a bunch of tests to document everything I've said and my medical records say about my cancer.

And somewhere towards the end of this, Tricia tells me that T-DM1 is going to be available in SEATTLE, in AUGUST. I felt like saying, "Well, then, why am I talking to you?" But she did say that I could start at Highland and transfer to Seattle later, but there is still all the cost and energy-suck of getting back and forth to S. California, which I would rather avoid if I could. 

If I am somewhat stable on the present regimen, then August may be perfect timing for me. So I will discuss this all with Dr. Lee when I see him next week for my regular appt. I'm also seeing Dr. Eulau next week for a follow-up on how my bone mets are doing, so there may be something there as well. 

I think I'll start gathering everything I need, and then I can be first in line when the UW opens its doors in August!

@ Jeanne Sather 2010. 

Dialing for T-DM1

When I saw Dr. Lee last week, we talked some more about T-DM1, the new breast cancer drug now beginning to be available on an expanded access (or compassionate use) basis from Genentech.

I told him that I couldn't go to Florida to get the drug, for all sorts of reasons, including the financial costs associated with flying there every three weeks, but also the costs in energy, emotional and physical. For where I'm at right now, the cross-country flight is a real barrier. 

We agreed to watch for a location on the West Coast--I was thinking if not Seattle, then San Francisco, because that is only a two-hour flight and I have friends in the Bay Area I can stay with. And I pledged myself to call the Genentech clinical trials hotline once a week for updates. 

So that is on my list of things to do this morning. 

Also, a reader posted a comment this morning saying that there is now a location in Southern California, and I need to ask about that.

Don't know what I'm talking about? 

Here's what the government clinical trials Web site has: T-DM1

And here's the number at Genentech to call if you want more information: 888-662-6728

@ Jeanne Sather 2010. 

 

Back Home on the Couch

Just a quick post, because I'm tired, I'm in pain, and I had a long and complicated day of medical appointments. 

The good news is my cyberknife treatments finished today, and I have the four-color certificate to prove it! I could have done without that bit of levity, but maybe other patients feel differently. 

I also got a hug and a nice goodbye (with a handful of chocolates) from one of my technicians, and that was appreciated. He took good care of me, and made things easy for me, and I will never stop noticing the many people around me who behave like this.

He did ask me if I was planning to celebrate tonight, and that hadn't even crossed my mind. When you have metastatic disease, the treatment never really stops, and in fact I have three weeks more of radiation starting Monday plus I have to go back on chemo, starting Thursday next week. So I won't be celebrating, exactly. 

I did bring home the mask I wore during my treatments, and I'll probably do something creative with that. 

Saw Dr. Lee the medical oncologist today, and he was a bit upset that the radiation to my hip hadn't begun yet, but I explained that things had gotten delayed over the holidays, kinda on purpose, and then I wanted to finish the cyberknife before starting the field radiation. 

He understood. 

We also talked about the new pain in my left hip, and he showed me the bone scan, which clearly shows a big area of disease right where the left leg bone goes into the hip. I forget what that part of the pelvis is called, but it's right where the pelvis takes the weight from my leg, so it will have to be radiated. 

I already have a call in to Dr. Eulau about that. My radiation therapy plan will have to be adjusted so that we can treat both hips at the same time. 

Then Dr. Lee the First and I discussed our further strategy for getting the neratinib on compassionate use grounds from Wyeth/Pfizer, and also set me up for some appointments with only targeted therapies, which I should be able to tolerate. So the drill will be Herceptin and Avastin by IV every three weeks, and Tykerb orally every day. That all starts again on Thursday next week. 

Ok. Signing off.  

The plan for the rest of the day: Light a fire. Eat the baked potato that is in the oven as I write this, with cottage cheese and grated parmesan on top. Drink lots (grapefruit juice mixed with sparkling water is my favorite right now). Watch old movies on the couch with Connie, who didn't get a walk again today. Oh, and load up on pain meds. 

I would go out and play catch with him, but the rain is pouring down and it's DARK, at 4 p.m. Life in the northern latitudes. 

@ Jeanne Sather 2010. 

A Footnote on Neratinib and Russian Livers

My favorite medical librarian sent me the link to a clinical trial that Wyeth is doing (or may have completed) on liver damage with neratinib. 

The thing that caught my eye is that the trial was conducted in RUSSIA. And one group of study participants (patients) were people with chronic liver disease and the other group were healthy people. (I sure hope these folks were compensated for putting their livers at risk!)

It's a Phase I trial, so they are only testing the toxicity. 

I'll try to get newer info on the results of this trial, which was supposed to finish in March of this year. 

Here's the link: Neratinib Clinical Trial Liver Damage

@ Jeanne Sather 2009. 

Researching Neratinib

I have an appointment with Dr. Lee this afternoon to discuss neratinib further. He is just back from the breast oncology meeting in San Antonio, and he should have information to share about neratinib from that meeting. 

I've spent the morning reading through some of the info that readers had forwarded to me, and I got some useful information from the breastcancer.org neratinib discussion board. All of these women are getting neratinib in a clinical trial, and some are getting a placebo--that would be a drag. 

Here's that link: Neratinib Clinical Trials

Several women taking neratinib have had serious problems with diarrhea, which is the Number One issue with the drug. Some 85 percent of women who take it get diarrhea. Some of them were able to bring this under control with immodium, or by cutting the dose, or both. Some weren't, and they really suffered. 

Supposedly the problem goes away with time, but at least one woman still had problems six weeks into the drug regimen. 

I didn't get any clear information about the possibility of liver damage, although it was mentioned, so I'll ask Dr. Lee what he learned about that. 

And of course I need to get an update from him on how our application to get neratinib on compassionate use grounds from Wyeth/Pfizer is going. Last time we talked, they needed the original pathology report on my cancer, and neither of us had a copy of that. It's buried somewhere in the depths of the University of Washington Medical Center's archives, I'm sure. 

I'm feeling better today, both physically and emotionally. Still moving kind of slowly, a bit low energy, but much better than yesterday. Hoping to take Connie for a short walk before I have to leave to see my doctor. 

@ Jeanne Sather 2009. 

Neratinib: 'Something May Be Happening ... '

During all the drama of the past couple of weeks--my getting sick while out of town, ending up in the hospital, and then having to make a decision about radiating the new tumor in my head--my battle to get the drug neratinib on compassionate use grounds kind of fell by the wayside. 

I didn't forget about it, especially since the new tumor in my skull means my cancer progressed--once again--while I was on chemo, but I couldn't DO much about it until I was home and feeling better, which I am. 

And in any case, the next move was Dr. Lee's: He was supposed to call the oncologist at Wyeth/Pfizer, Dr. Anna Berkenbilt, to see if the drug company was willing to give me neratinib on compassionate use grounds. (I don't qualify for any of the clinical trials of this drug, because my chemo history is too long.)

So I waited until my appointment with Dr. Lee today, fully prepared for the answer to be "NO," and mentally planning what I was calling "The Battle for Neratinib" ... but I got a surprise. 

Dr. Lee talked to Dr. Berkenbilt just before my appointment, and her answer was, "Something may be happening."

OK, so that's not quite yes, but then she went on to talk to Dr. Lee about all the paperwork involved and to caution him that the paperwork and so on would probably take a couple of weeks, which is actually just about right for me, since I need to get the tumor in my head zapped first. 

I have volunteered to write as much of the application as I can and then give it to Dr. Lee for editing and his additions, because, quite honestly, he doesn't have the time to do this. My entire cancer history--all 11 years of it--is just one little part of that application. 

As I've said before, it's a wonder that any sick person ever succeeds in getting a drug they need this way. And, in fact, not many do. But that's another post for another day. 

Tomorrow I start writing this puppy!

See also: Neratinib

Support this blog:

@ Jeanne Sather 2009.